Welcome to FDLI
The Food and Drug Law Institute is committed to providing high quality education and a neutral forum for the generation of ideas and discussion of law and public policy for its legal, policy and regulatory communities.
November 18-19 | The Madison Hotel | Washington, DC
The Food & Drug Administration (FDA) has been and remains the focus of all new drug and medical device approvals and post-approval monitoring of existing healthcare products and technologies. However, this agency no longer rules alone. Given the heightened focus on economic considerations, a sleeping giant has awakened! The Centers for Medicare and Medicaid Services (CMS) impact all decisions regarding drug development, clinical trials, and post-approval uses and reimbursements. Learn More >
Import Regulation: Protecting U.S. Consumers in a Global Economy
October 24 | The Madison Hotel | Washington, DC
Ensuring the safety of imported products presents numerous challenges faced by the U.S. Food and Drug Administration (FDA) and industry This conference will examine FDA's current legal authority to use U.S. law to inspect, regulate and bring enforcement actions against companies that operate entirely outside the U.S.to produce regulated products ultimately offered for sale here. The conference will also discuss potential legislative approaches available for expanding the power of the FDA to more effectively police imported products Finally, the conference will consider the extent to which national regulatory systems, international cooperation and private sector collaboration, as discussed by Health and Human Services Secretary Michael O. Leavitt during an Interagency Import Safety Summit, can effectively facilitate global trade while protecting the health and safety of U.S. consumers. Learn More >